Editorial: Safety and side effects of psychotropic medications

Filippis, Renato de; Solerdelcoll, Mireia; Shalbafan, Mohammadreza

doi:10.3389/fpsyt.2023.1148158

Cited by 7 publications

(7 citation statements)

References 16 publications

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“…More ADEs appeared to be associated with lower concentrations, but this result is not convincing from the perspective of pharmacokinetics/pharmacodynamics. From the perspective of long-term medication, considering the large utilization of CIT and the evidence gap, CIT-related safety should be paid more attention to ( 30 ). Third, with regard to the therapeutic range of CIT (50–110 ng/mL) recommended by clinical guidelines and expert consensus, no evidence was found on the upper limit of concentration.…”

Section: Discussionmentioning

confidence: 99%

Toward therapeutic drug monitoring of citalopram in depression? Insights from a systematic review

Song

Jiang

et al. 2023

Front. Psychiatry

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BackgroundWithin the framework of individualized psychopharmacotherapy, therapeutic drug monitoring (TDM) has gained increasing relevance. In the absence of high-quality evidence, the TDM of citalopram (CIT) and the recommended therapeutic ranges of the plasma concentrations have been proposed by guidelines. However, the correlation between the plasma concentration of CIT and treatment outcomes has not been well established. Therefore, the aim of this systematic review was to evaluate the relationship between plasma CIT concentration and treatment outcomes in depression.Research design and methodsPubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Chinese databases (CNKI, Wanfang Data and Sinomed) were searched up to August 6, 2022. We included clinical studies evaluating the correlation between the plasma CIT concentration and treatment outcomes in patients with depression receiving CIT treatment. Outcomes measured included efficacy, safety, medication adherence, and cost-related outcomes. A narrative synthesis was performed to summarize findings from individual studies. This study was performed according to the Preferred Reporting Items for Systematic Reviews, Meta-Analysis (PRISMA) and the reporting guideline for Synthesis without meta-analysis (SWiM).ResultsEleven studies involving 538 patients were included in total. The reported outcomes were mainly efficacy (n = 11) and safety (n = 3); one study reported the duration of hospitalization, and no study reported medication adherence. Regarding the efficacy outcomes, three studies revealed the plasma CIT concentration-response relationship and proposed a lower limit of 50 or 53 ng/mL, whereas this was not found in the rest of the studies. Regarding adverse drug events (ADEs), one study reported more ADEs in the low-concentration group (<50 ng/mL vs. >50 ng/mL), which is not convincing from the perspective of pharmacokinetics/pharmacodynamics. Regarding the cost-related outcomes, only one study reported that the high CIT concentration group (≥50 ng/mL) contributed to shortening the hospitalization duration, but it did not provide detailed information, including direct medical expenses and multiple potential factors contributing to longer hospital stays.ConclusionsA definite correlation between plasma concentration and clinical or cost-related outcomes of CIT cannot be drawn, whereas a tendency toward improved efficacy in patients with plasma concentration above 50 or 53 ng/mL was suggestive from limited evidence.

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Section: Discussionmentioning

confidence: 99%

Toward therapeutic drug monitoring of citalopram in depression? Insights from a systematic review

Song

Jiang

et al. 2023

Front. Psychiatry

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“…Drug holidays is defined as temporarily stopping or reducing the dose of medication. It has previously been used to help alleviate side effects or improve the effectiveness of the primary medication for the treatment of various mental disorders [ 9 , 10 ].…”

Section: Introductionmentioning

confidence: 99%

The effect of drug holidays on sexual dysfunction in men treated with selective serotonin reuptake inhibitors (SSRIs) other than fluoxetine: an 8-week open-label randomized clinical trial

Alipour-Kivi,

Eissazade,

Shariat

et al. 2024

BMC Psychiatry

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Introduction Selective serotonin reuptake inhibitors (SSRIs) are widely used for the treatment of various mental disorders. Sexual dysfunction is one of the most common side effects of SSRIs, and often leads to poor adherence and treatment discontinuation. While several strategies have been employed to manage SSRI-induced sexual dysfunction, drug holidays has not been extensively studied for this purpose. This clinical trial aims to assess the effect of drug holidays on sexual dysfunction in married men under treatment with SSRIs other than fluoxetine (as its long half-life makes drug holidays ineffective). Methods This 8-week double-center, randomized, open-label, controlled trial was conducted in the outpatient clinics of Iran Psychiatric Hospital and Tehran Institute of Psychiatry, from January 2022 to March 2023. We included married men aged between18 and 50 years who had experienced sexual dysfunction during treatment with SSRIs, other than fluoxetine. The Male Sexual Health Questionnaire (MSHQ) and the 28-Question General Health Questionnaire (GHQ-28) were used for the assessment of sexual function and mental health status. The drug holidays group was instructed not to take their medications on the weekends. The control group was asked to continue their regular medication regimen without any changes. Both groups were assessed at baseline, and weeks 4 and 8. Results Sixty-three patients were included and randomly assigned to the drug holidays group (N = 32) or the control group (N = 31). Fifty patients (25 in each group) completed the trial. Drug holidays significantly improved erection, ejaculation, satisfaction, and the overall sexual health of the participants (P < 0.001). No significant change was observed in their mental health status. No major side effects were recorded. Conclusions Drug holidays significantly improved the MSHQ scores in ‘erection’, ‘ejaculation’, ‘satisfaction’ and ‘total’ in married men with sexual dysfunction induced by SSRIs, other than fluoxetine, without causing any significant changes in their mental health status. Further research is needed to reach a certain conclusion. Trial registration The trial was registered at the Iranian Registry of Clinical Trials on 2021.10.25 (www.irct.ir; IRCT ID: IRCT20170123032145N6) before the trial.

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“…Several strategies have been explored to address this issue, as discussed in a comprehensive 2013 Cochrane review: the 'wait-and-see' approach, behavior-changing techniques, psychotherapy, dose reduction, delaying the dose until sexual activity, switching to a different medication, adjuvant therapy, and drug holidays. However, due to a lack of diversity in clinical trials, no definitive conclusion can be drawn regarding the safety and efficacy of these strategies [5,6].…”

Section: Introductionmentioning

confidence: 99%

“…Drug holidays involves temporarily discontinuing or reducing the medication dosage to alleviate the associated side effects. Drug holidays has specifically been recommended for delayed orgasms and anorgasmia [5][6][7][8][9]. However, research in this area is limited, with only one 4-week clinical trial reporting significant improvement of sexual function, without any significant changes in depressive symptoms, except in those receiving fluoxetine, possibly due to fluoxetine's long half-life [8,9].…”

Section: Introductionmentioning

confidence: 99%

Safety and Efficacy of Drug Holidays for Women with Sexual Dysfunction Induced by Selective Serotonin Reuptake Inhibitors (SSRIs) Other than Fluoxetine: An Open-Label Randomized Clinical Trial

Lalegani,

Eissazade,

Shalbafan

et al. 2023

Brain Sciences

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Selective serotonin reuptake inhibitors (SSRIs) are the cornerstone of psychopharmacology. However, they cause side effects such as sexual dysfunction, leading to the discontinuation of treatment. We aimed to investigate the efficacy and safety of drug holidays for women experiencing sexual dysfunction Induced by SSRIs other than fluoxetine. This study was an 8-week randomized, open-label, controlled trial including married women aged between 18 and 50 years who had experienced sexual dysfunction while undergoing treatment with SSRIs. The intervention group implemented drug holidays by not taking medications on Thursdays and Fridays, while the control group continued regular medication use. The female sexual function index (FSFI) and the 28-question general health questionnaire (GHQ-28) were administered to assess sexual function and mental health, respectively. A total of 50 participants completed the trial. The drug holidays’ group showed significant improvements in arousal (p < 0.001), desire (p = 0.001), orgasm (p < 0.001), satisfaction (p < 0.001), lubrication (p = 0.021), and overall sexual health (p < 0.001). The between-group difference of pain was significant (p < 0.001), despite no significant within-group change. Mental health improved in both groups, despite no significant between-group difference. No major adverse effects were reported. Drug holidays did not introduce immediate safety concerns or significant adverse effects during the timeframe of eight weeks, suggesting that it may be a safe and effective strategy for managing SSRI-induced sexual dysfunction in women, alongside improving mental health. Further research is needed to reach a definitive conclusion.

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Editorial: Safety and side effects of psychotropic medications

Cited by 7 publications

References 16 publications

Toward therapeutic drug monitoring of citalopram in depression? Insights from a systematic review

Toward therapeutic drug monitoring of citalopram in depression? Insights from a systematic review

The effect of drug holidays on sexual dysfunction in men treated with selective serotonin reuptake inhibitors (SSRIs) other than fluoxetine: an 8-week open-label randomized clinical trial

Safety and Efficacy of Drug Holidays for Women with Sexual Dysfunction Induced by Selective Serotonin Reuptake Inhibitors (SSRIs) Other than Fluoxetine: An Open-Label Randomized Clinical Trial

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